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A Trial to Investigate the Effect of Different Supplements on Fluid and Sodium Status in Short Bowel

Primary Purpose

Short Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vital 1.5
Ensure Plus
Sponsored by
London North West Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Short Bowel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients (>18 years)
  • Residual length of small bowel <200cm determined either at operation or radiologically.
  • Patients with a stoma or an established enterocutaneous fistula
  • Normal hydration status (urinary sodium >20mmol/L)

Exclusion Criteria:

  • Dehydration (urinary sodium <20mmol/L)
  • Patients with short bowel and a jejunocolonic anastomosis
  • Current sepsis of any cause
  • Addition/amendment to anti-diarrhoeal or anti motility agents in the last 3 days
  • Severe gastrointestinal obstruction or structural abnormality of the intestine
  • Active Crohn's disease - assessed using two of the three parameters:

CReactive Protein >10 Albumin <30g/L Platelets >400

  • Participation in another intervention trial which may affect intestinal absorption
  • Nil by mouth
  • Unable or unwilling to provide consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Vital 1.5

    Ensure Plus

    Arm Description

    200ml orally over 30 minutes

    200ml orally over 30 minutes

    Outcomes

    Primary Outcome Measures

    Change in faecal sodium
    Change in faecal sodium

    Secondary Outcome Measures

    Full Information

    First Posted
    February 5, 2016
    Last Updated
    October 13, 2022
    Sponsor
    London North West Healthcare NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02686606
    Brief Title
    A Trial to Investigate the Effect of Different Supplements on Fluid and Sodium Status in Short Bowel
    Official Title
    A Randomised Controlled Crossover Trial to Investigate the Effect of Different Oral Nutritional Supplements on Fluid and Sodium Status in Patients With Short Bowel Intestinal Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (Actual)
    Primary Completion Date
    November 2019 (Actual)
    Study Completion Date
    March 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    London North West Healthcare NHS Trust

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patients with short bowel intestinal failure are recommended to aim for a diet high in energy and protein. Some patients have difficulties in achieving recommended intakes and additional nutrition may be provided by oral nutritional supplements. There is very little research completed on which is the best oral nutritional supplement for patients. The aim of the study is to see the effect different oral nutritional supplements have on your stoma or fistula output and levels of hydration.
    Detailed Description
    After written consent is obtained, patients will be asked to fast from 12.00am on day one. At 08.00am patients will be asked to pass urine and to empty their stoma bag. After this they will be asked to drink 200ml of the ONS which they have been randomised to test on day one over a 30 minute period. Urine and intestinal output will be collected into two separate containers over the next 6 hours. During this time the patient will not be permitted to eat or drink other fluids. After 6 hours the patient will be able to eat and drink normally. The urine and intestinal output will be weighed and then an aliquot will be stored in a -20oC freezer before being sent for analysis. Day two is a washout day when the patient will be able to eat and drink normally. Day three will be the same as day one but the patient will have the other ONS that they did not have on day one. No changes will be made to the patient's usual anti diarrhoeal and/or anti motility agents or parenteral support during the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Short Bowel Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vital 1.5
    Arm Type
    Experimental
    Arm Description
    200ml orally over 30 minutes
    Arm Title
    Ensure Plus
    Arm Type
    Active Comparator
    Arm Description
    200ml orally over 30 minutes
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Vital 1.5
    Intervention Description
    Oral nutritional supplement
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Ensure Plus
    Intervention Description
    Oral nutritional supplement
    Primary Outcome Measure Information:
    Title
    Change in faecal sodium
    Description
    Change in faecal sodium
    Time Frame
    Day 1 and 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients (>18 years) Residual length of small bowel <200cm determined either at operation or radiologically. Patients with a stoma or an established enterocutaneous fistula Normal hydration status (urinary sodium >20mmol/L) Exclusion Criteria: Dehydration (urinary sodium <20mmol/L) Patients with short bowel and a jejunocolonic anastomosis Current sepsis of any cause Addition/amendment to anti-diarrhoeal or anti motility agents in the last 3 days Severe gastrointestinal obstruction or structural abnormality of the intestine Active Crohn's disease - assessed using two of the three parameters: CReactive Protein >10 Albumin <30g/L Platelets >400 Participation in another intervention trial which may affect intestinal absorption Nil by mouth Unable or unwilling to provide consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    alison culkin, PhD
    Organizational Affiliation
    London Northwest Healthcare Trust
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Trial to Investigate the Effect of Different Supplements on Fluid and Sodium Status in Short Bowel

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